Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer

Pengyuan Liu

Status and phase: Enrolling; Phase 2

Conditions: Metastatic Castration-resistant Prostate Cancer (CRPC)

Treatments: Drug: Immunotherapy; Drug: Targeted therapy; Device: Hyperthermia

Study type: Interventional

Funder types: Other

Identifiers

NCT06249750

HEAIS007

Details and patient eligibility

About

In this study, we propose to use the combination of ET-SPACE NIR irradiation whole-body thermal stimulation, ICI (Tislelizumab), and RTK inhibitor (Anlotinib) in the multimodal treatment of CRPC.

Full description

The initial efficacy and safety of the multimodal therapy will be evaluated at the animal level to fully validate the potential feasibility of the therapy. Subsequently, the efficacy of the multimodal therapy will be verified at the organoid level, and based on which a translational randomized controlled clinical trial will be conducted to evaluate the efficacy and safety of the multimodal therapy at the human level, and the patients will be followed up for a long period of time, so as to collect detailed data on improvement of the quality of life. Finally, the synergistic effect of the multimodal therapy will be analyzed at the molecular and cellular levels.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histopathologically confirmed diagnosis of PC and clinically confirmed diagnosis of CRPC;
• Complete and reliable medical history and medical records;
• No other primary tumors except CRPC;
• Blood tests, liver function, renal function and electrocardiogram are basically normal;
• Patients with ECOG score 0~3, aged ≥18 years and <90 years old;
• Patients with good compliance, able to accept regular follow-up.

Exclusion criteria

• History of malignant tumor other than PC within the past 5 years;
• Severe abnormalities in the patient's laboratory indices may jeopardize patient safety or compromise this study;
• Accompanied by severe underlying diseases that cannot tolerate this therapy;
• With acute diseases, such as acute infection, active bleeding;
• Those who have recently participated in other clinical trials and have not passed the washout period;
• Those who cannot tolerate systemic heat stress, such as claustrophobic patients;
• Those who have a history of allergy to the drugs used in the trial;
• Patients with other reasons for not being able to be enrolled in the study, according to the study doctor.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Immuno-targeted therapy group

Experimental group

Description:

ICI regimen: Tislelizumab, 200mg, ivgtt., d1, q21d; RTK inhibitor regimen: Anlotinib, 12mg (at an initial dose of 12mg, later adjusted according to the instructions), po., d1\~14, q21d.

Treatment:

Drug: Targeted therapy

Drug: Immunotherapy

Hyperthermia-immuno-targeted therapy group

Experimental group

Description:

ET-SPACE near-infrared irradiation whole-body hyperthermia: d1, d8, q21d, rectal temperature reaches 38.5\~39 ℃ and then maintain 1h. ICI regimen: Tislelizumab, 200mg, ivgtt., d2, q21d; RTK inhibitor regimen: Anlotinib, 12mg (at an initial dose of 12mg, later adjusted according to the instructions), po., d2\~15, q21d.

Treatment:

Device: Hyperthermia

Drug: Targeted therapy

Drug: Immunotherapy